CP-690,550 and Midazolam Drug-Drug Interaction Study

A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902460

Enrollment

Registered

2009-05-15

Start date

2009-06-30

Completion date

2009-07-31

Last updated

2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents

Brief summary

CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.

Interventions

DRUGmidazolam; CP-690,550 + midazolam

Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID

DRUGCP-690,550 + midazolam; midazolam

Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female (non-child bearing potential) subjects

Exclusion criteria

* Clinically significant infections within the past 3 months * History of previously untreated infection with Mycobacterium tuberculosis * Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Design outcomes

Primary

Measure	Time frame
AUCinf of midazolam	10 Days

Secondary

Measure	Time frame
AUClast, Cmax, Tmax, t1/2 of midazolam	10 Days
Vital signs, laboratory tests and adverse events	10 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026